The present invention is in the technical field of dentistry. More particularly, an oral appliance and method of making an oral appliance are provided, including a bite registration device for use by dentists to determine and record the correct patient bite position for a laboratory to fabricate an oral appliance.
The airway of humans has no bony support. This unique condition has the distinct advantage of facilitating speech, a very valuable adaptation, but has disadvantages as well—choking, snoring and apnea. Snoring and obstructive Sleep Apnea Syndrome (“OSAS”) are the manifestations of collapse of the flexible, compliant human airway.
Snoring is defined as obstructive sleep breathing, characterized by a harsh, loud sound. Snoring is a partial collapse of the tongue on the airway. Three conditions are necessary for snoring to occur: (1) sleep, (2) airflow limitation, and (3) vibrating structure in the airway. Snoring is a condition affecting approximately 40% of the population. Snoring can disrupt the sleep, not only of the snorer, but the sleep partner as well, having profound effects on their daytime quality of life.
OSAS has been reported to occur in up to 7 or 8% of the population. The tongue during sleep loses it natural tonus and can collapse into the airway, blocking airflow. Apnea literally means lack of breath. OSAS is a condition that occurs during sleep when a person is trying to breathe and get air, but the airway is blocked by the tongue. Airway blockage for a period of at least 10 seconds with effort being made to breathe is the definition of an apneic event. The apneic blockage is ended by a gasp, causing an arousal that disrupts normal sleep architecture.
The four commonly utilized therapies to treat snoring and sleep apnea are CPAP (continuous positive air pressure) therapy, surgery, lifestyle changes and oral airway dilators. CPAP works well, but it is uncomfortable, requires wearing a mask attached to a positive pressure pump, and creates a bloated feeling. Surgery is painful and invasive, and has a success rate of less than 50%. Lifestyle changes such as weight loss, exercise, no alcohol consumption, dietary counseling and food restrictions have very low compliance. Oral airway dilators have high patient compliance, and are comfortable and effective, particularly in cases of mild to moderate OSAS. The drawbacks of known oral airway devices are that some restrict tongue protrusion by their design of anterior mandibular advancement mechanisms, some cause tooth movement by incorporating retentive clasps on teeth, others cause gagging by tongue depression, and some have frequent breakage. The color of many such devices, which are constructed with clear methyl-methacrylate material, deteriorate in color with time, becoming an unpleasant shade of yellow.
Further, when fabricating an oral dental device, such as an oral airway dilator, for example, the prescribing dentist must determine the relationship in space in all dimensions of the mandibular (lower) arch in relation to the maxillary (upper) arch. Bite registration devices are provided between the patient's upper and lower arches and record an imprint of the patient's maxillary and mandibular teeth and ridges in the prescribed position. The bite registration is later used by a laboratory along with stone casts that are made from impressions of the patient's upper and lower arches. The stone casts are mounted on an articulator with the bite registration between the maxillary and mandibular arches in the exact position that the dentist prescribes. This process facilitates the proper fit of the oral dental device for the patient.
Historically, wax was the substance used to record the patient's bite. However, a bite recorded in wax is not stable as it may warp, bend and/or become brittle, depending on how it is handled and stored. If any of these above occurrences happens to the wax bite, the bite will not be a proper replica of the relationship between the maxillary and mandibular arches.
Certain conventional bite registration devices require the lips to be separated in order to record a full arch bite. Breathing through the nose with the lips closed is the healthiest physiological condition for sleep. If an individual's jaws are so far apart that he or she cannot comfortably close the lips, he or she will breathe through the mouth. The lips should be closed when the future oral dental device is in the mouth.
Certain conventional bite registration devices may not allow the distance between a patient's maxillary and mandibular arches to be easily varied. However, it may be desirable for a prescribing dentist to select a custom distance between a patient's maxillary and mandibular arches.
In light of the foregoing, there is a need for improved oral airway dilators and methods of making oral appliances. Such improved methods of making may include improved bite registration devices.